Director, TMF Operations

<div class="content-intro"><p>Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.</p></div><p><strong>The Role:</strong></p> <p>Reporting to the Senior Director of Clinical Operations, the Director, TMF Operations leads Immunovant’s TMF transformation and ongoing TMF operations to deliver a governed, inspection-ready TMF operating model. The role will drive TMF strategy, quality, oversight, and inspection readiness, including TMF governance, a harmonized Sponsor TMF definition across systems and partners, and a CRO model that demonstrates sponsor oversight. The Director drives the shift to process-centric TMF management by embedding TMF outputs into core clinical processes, implementing risk-based oversight, and delivering KPIs and dashboards for completeness, timeliness, and risk. This role partners with Clinical Operations, Quality/Compliance, Regulatory, IT/eTMF, Alliance Management, and Procurement/Legal to ensure compliant processes, systems, training, and documentation.</p> <p><strong>Key Responsibilities:&nbsp;</strong></p> <ul> <li>Lead the TMF operating model, including strategy, governance, standards, and operating model to support portfolio</li> <li>Define and implement TMF processes, standards, and KPIs to promote consistency, quality, and compliance across studies and vendors utilizing a risk-based approach to ensure sponsor oversight</li> <li>Oversee TMF across all programs, ensuring alignment with ICH-GCP, TMF Reference Model, and global regulatory expectations</li> <li>Lead TMF oversight in an outsourced model, driving CRO/vendor accountability for TMF completeness, quality, and timeliness, including dashboards and governance reporting to senior leadership</li> <li>Establish and drive TMF health metrics, risk indicators, and escalation pathways across studies</li> <li>Serve as the TMF subject matter expert, guiding cross-functional teams, influencing best practices, supporting role-based training for sponsor and CRO teams, and monitoring adoption and uptake through metrics and governance</li> <li>Lead and support TMF-related activities for health authority inspections (FDA, EMA, and other regulatory agencies)</li> <li>Drive continuous inspection readiness by defining, implementing and improving the TMF/eTMF operating model and performance program</li> <li>Serve as TMF lead/SME for TMF-related inspections and QA audit activities</li> <li>Drive TMF inspection preparation, SME briefing, document retrieval, and response coordination including TMF demonstrations, evidence packages and remediation planning</li> <li>Lead or support remediation and CAPA development for TMF-related inspection findings</li> <li>Drive eTMF system strategy and governance, including:</li> <ul> <li>System configuration, taxonomy, and metadata standards</li> <li>Lead cross system TMF artifact mapping and reconciliation across eTMF, CTMS, eDC, safety, regulatory and QMS to support trial reconstruction</li> <li>Vendor/system performance and optimization</li> <li>Partner with CBO Ops, IT and quality systems on validation and change control for eTMF and related systems, as applicable</li> <li>Oversight of enhancements, releases, and UAT</li> </ul> <li>Drive TMF quality at scale by:</li> <ul> <li>Establishing QC/QR frameworks and oversight models</li> <li>Driving effective TMF reconciliation practices across functions and vendors</li> <li>Identifying systemic gaps and implementing continuous improvement initiatives</li> </ul> <li>Provide leadership and oversight to TMF staff and/or vendors, including mentoring and capability building</li> <li>Partner cross-functionally with Clinical Operations, Study Teams, QA, Regulatory, and external partners to drive end-to-end TMF alignment</li> <li>Lead and support TMF-related risk management, including proactive identification and mitigation of compliance risks</li> <li>Lead or support TMF migrations, system implementations, and vendor transitions</li> <li>Partner with Procurement/Legal and Alliance Management to embed TMF expectations in contracts and SOWs (access, reporting, audit rights, inspection support)&nbsp;</li> </ul> <p><strong>Requirements: </strong></p> <ul> <li>BS/BA degree required, advanced degree highly desirable</li> <li>8–12+ years of clinical research experience, including significant TMF/eTMF leadership experience</li> <li>Proven experience in building and leading TMF frameworks in an outsourced or hybrid operating model</li> <li>Deep expertise in TMF strategy, governance, inspection readiness, and health authority inspections (FDA, EMA)</li> <li>Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements</li> <li>Extensive experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including system governance and optimization</li> <li>Experience managing CROs/vendors and holding them accountable for TMF quality and delivery</li> <li>Excellent communication and ability to represent TMF in regulatory-facing settings</li> <li>Demonstrated excellence in complex project management and effective management of multiple projects/priorities</li> <li>Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.</li> <li>Demonstrated ability to lead cross-functional initiatives and influence at a senior level</li> <li>Strong leadership, strategic thinking, and decision-making skills</li> </ul> <p><strong>Work Environment:</strong></p> <ul> <li>Dynamic, interactive, fast-paced, and entrepreneurial environment</li> <li>The position is for remote work</li> <li>Domestic travel required (up to 10%)</li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">Salary range for posting</div><div class="pay-range"><span>$200,000</span><span class="divider">&mdash;</span><span>$225,000 USD</span></div></div></div><div class="content-conclusion"><p>Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.</p> <p>&nbsp;</p></div>